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Life Sciences Blog

Stay updated with the latest insights in life sciences! Our blog explores cutting-edge advancements, regulatory updates, and expert perspectives across pharmaceuticals, biotechnology, and medical devices. From innovation to implementation, discover valuable knowledge to support quality and compliance in the life science industry.

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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/Is-your-product-a-medical-device-Well-that-depends%E2%80%A6-QbD-Oct-07-2024-11-11-08-5266-AM.jpg

What is a medical device? Key definitions and regulations around the world.

What is a medical device? This crucial question often arises when bringing medical devices to market. Determining whether your product qualifies as a...
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UDI for software: how to mark your MDSW with a UDI?

We recently published a blog post about Unique Device Identifiers (UDI). While this blog post briefly explains what a UDI is and how to implement it on...
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MDR impact on MDSW: what has changed from MDD?

Are you aware that the introduction of MDR may have affected your CE-marked medical software (MDSW)? Or will affect the CE marking of your first or next...
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SaMD versus MDSW: what’s the difference between Software as a Medical Device and Medical Device SoftWare?

Nowadays, digital healthcare is taking an increasingly important place in the medical world through medical software, image processing, diagnostic support,...
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